Table 1.
Current MSC-approved treatments.
| Name/Year | Company | Origin | Use | Description | Dosage | AT/AL | Charge |
|---|---|---|---|---|---|---|---|
| Queen-cell/2010 [1,27] | Anterogen (Republic of Korea) | Republic of Korea MFDS | Connective tissue disorders | A heterogeneous mixture of AT-MSCs and other cell types such as pre-adipocytes, endothelial progenitor cells, pericytes, mast cells, and fibroblasts | 1 × 10⁶ cells/mL | AT | NA |
| Cellgram AMI/2011 [1,28] | Pharmicell (Republic of Korea) | Republic of Korea MFDS | AMI | Human BM-MSCs | a. Under 60 kg = 10 mL/5.0 × 10⁷ BM-MSCs b. 61–80 kg = 14 mL/7.0 × 10⁷ BM-MSCs c. >80 kg = 18 mL/9 × 10⁷ BM-MSCs |
AT | USD 15,000 per shot |
| Cupistem/2012 [1,27,38] | Anterogen (Republic of Korea) | Republic of Korea MFDS | Crohn’s fistula | Human-adipose-tissue-derived MSCs | Fistula diameter: (a) ≤1 cm (3 × 10⁷ MSCs in 1 mL) (b) 1 < X< 2 cm (6 × 10⁷ MSCs in 2 mL) |
AT | USD 5000 per treatment |
| Cartistem/2012 [1,29] | Medipost (Republic of Korea) | Republic of Korea MFDS | Knee OA (ICRS grade IV) | Human-umbilical-cord-blood-derived MSCs | 7.5 × 10⁶ cells/vial (depending on the size of the lesion) | AL | USD 21,000 per treatment |
| NeuroNataR/2014 [1,30,39] | Corestem (Republic of Korea) | Republic of Korea MFDS | ALS | Human BM-MSCs | 1 × 10⁶ BM-MSCs/kg Twice every 4 weeks | AT | USD 55,000 annually |
| Holoclar/2015 [35,40] | Chiesi Farmaceutici | EMA | Limbal stem cell deficiency due to ocular burns | Limbal stem cells | 79,000–316,000 cells/cm² | AT | USD 80,000 per eye |
| Reme-stemcel-L/2015 [1,5,8] | Mesoblast, Ltd. (Australia) | US FDA | Acute and refractory GvHD for pediatric patients | Human BM-MSCs | IV administration: Low (2 million cells/kg) High (8 million cells/kg) |
AL | USD 200,000 per treatment |
| Temcell HS/2015 [1,31,41] | JCR Pharmaceuticals (Japan) | Japan PMDA | Acute and refractory GvHD | Human BM-MSCs | IV infusion of 2 million cells/kg (each bag contains 72 million cells in 18 mL of saline); 4 mL per minute twice weekly in intervals of 3 days or more for 4 weeks | AL | USD 7600 per bag |
| Stem-peucel/2016 [1,33] | Stem-peutics Research Bangalore (India) | India DCGI | CLI | Human BM-MSCs | Intramuscular injection of 1 or 2 million cells/kg body | AL | USD 2200 per treatment |
| Alofisel/2018 [1,36,42] | TiGenix (US) and Takeda (UK) | EMA | Complex perianal fistulas in CD | Human-adipose-tissue-derived MSCs | Vial: 30 million MSCs/6 mL Treatment: 4 vials |
AL | USD 47,485 per treatment |
| Mesestro-Cell/2018 [1,34] | Cell Tech Pharmed (Iran) | Iran FDA | OA | BM-MSCs | A minimum intra-articular injection of 2 × 10⁷ cells/knee; in total, 4 × 10⁷ cells for both knees | AT | NA |
| Stemirac/2018 [32,43] | Nipro Corp | Japan PMDA | Spinal cord injury | BM-MSCs | 50 to 200 million cells | AT | USD 135,000 |
AL: allogeneic, ALS: amyotrophic lateral sclerosis, AMI: acute myocardial infarction, AT-MSCs: MSCs from adipose tissue, AT: autologous, BM: bone marrow, CD: Crohn’s disease, CLI: critical limb ischemia, DCGI: Drug Controller General of India, EMA: European Medicine Agency, FDA: Food and Drug Administration, GvHD: graft versus host disease, ICRS: International Cartilage Repair Society, IV: intravenous, MFDS: Ministry of Food and Drug Safety, MSCs: mesenchymal stem cells, NA: not available, OA: osteoarthritis, PMDA: Pharmaceuticals and Medical Devices Agency, UK: United Kingdom, US: United States.